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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04247217
Other study ID # PRIMUS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 19, 2020
Est. completion date December 23, 2021

Study information

Verified date May 2022
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.


Description:

Prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage HDR brachytherapy in MAASTRO Clinic, Maastricht. HDR treatment is standard in Maastro Clinic for local relapses of prostate cancer after previously irradiation (internal or external). Biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment). Several immunotyping (expression of PD-(L)-1, CXCL12, IL-23 receptor, etc.) and HLA class I expression will be performed on the biopsies. In addition, HLA genotypes will be determined on DNA isolated from pheripheral blood. The plasma and the biopsies will be stored for eventually additional research.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 23, 2021
Est. primary completion date December 23, 2021
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Local relapse of prostate cancer, who is candidate for a salvage HDR treatment: - Biochemical relapse (PSA increase) - Local relapse on imaging: PSMA scan, mp-MRI - Pathology proven relapse - Willing and able to comply with the study prescriptions. - 18 years or older - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: - Not eligible for proposed (HDR brachytherapy) treatment: - Life expectancy < 10 years - Distant Metastasis - Recently TURP with big urethral defect - Not able to stop anticoagulants - Flow < 10 ml/sec • No compliance to study procedure

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
HDR salvage brachytherapy
In patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points.

Locations

Country Name City State
Netherlands Maastro Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expression of PD-(L)-1 receptor Expression of PD-(L)-1 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points. up to 28 days
Secondary Expression patterns of CXCL12 Expression of CXCL12 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Expression patterns of IL-23 Expression of IL-23 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Expression patterns of MDSC Expression of MDSC receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Changes in T cell infiltration profiles Changes in T cell infiltration profiles induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Changes in HLA class I-A expression on tumor cells Changes in HLA class I-A expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Changes in HLA class I-B expression on tumor cells Changes in HLA class I-B expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
Secondary Changes in HLA class I-C expression on tumor cells Changes in HLA class I-C expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points up to 28 days
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